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Psych Congress  

Efficacy of Cariprazine on YMRS Single Items: A Pooled Analysis of 3 Randomized, Double-Blind, Placebo-Controlled Trials in Bipolar Mania

Adam Ruth, PhD. Stephen Zukin, MD. John Kane, MD. Andrew Cutler, MD. Yao Wang, MD. Kaifeng Lu, PhD. Adam Ruth, PhD. Krisztián Nagy, MD. István Laszlovszky, PharmD, PhD. Suresh Durgam, MD. György Németh, MD, PhD.
Forest Laboratories, Inc. and Gedeon Richter Plc

Background: Cariprazine is an orally active and potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors currently in development for the treatment of bipolar mania. Cariprazine demonstrated efficacy in 3 randomized, double-blind, placebo-controlled trials in bipolar mania. This pooled analysis of these trials evaluated the efficacy of cariprazine on YMRS single-items.

Methods: Data were pooled from 3 similarly designed cariprazine studies in patients with acute manic or mixed episodes associated with bipolar I disorder. Patients in all 3 studies received placebo or cariprazine (flexibly dosed 3-12 mg/day in 2 studies; fixed/flexible dosed 3-6 mg/day or 6-12 mg/day in the third study) for 3 weeks of double-blind treatment. Post hoc pooled analysis analyzed change from baseline to Week 3 in individual Young Mania Rating Scale (YMRS) items using an MMRM approach.

Results: The pooled dataset included 1037 patients (cariprazine, n=608; placebo, n=429). In each of the individual trials, cariprazine showed significant advantage vs placebo on YMRS total score improvement (LSMD: -4.3 to -7.0; P<.0001 [all 3 studies]). In the pooled analyses, the LSMD for cariprazine vs placebo was significant for all 11 YMRS items (all items, P<.0001). In general, CAR treatment showed at least moderate effect sizes (Cohen’s d) on all YMRS items, with estimates ranging from -0.31 (increased motor activity) to -0.55 (irritability). 

Conclusion: Cariprazine demonstrated efficacy on all individual YMRS items in this pooled analysis. These results suggest that cariprazine has broad efficacy across symptoms in the treatment of acute mania associated with bipolar I disorder.  

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